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Methylprednisolone for Knee Arthritis

Phase 4

Recruiting

Led By Ajay Premkumar, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery

Awards & highlights

Study Summary

This trial looks at whether taking anti-inflammatory drugs (glucocorticoids) after knee replacement surgery can reduce pain, nausea and opioid use in the weeks after surgery.

Who is the study for?

This trial is for patients aged 18 to 95 who are undergoing their first total knee replacement due to severe knee arthritis. It's not suitable for those with other conditions that might affect the surgery or recovery.Check my eligibility

What is being tested?

The study tests if a short-term steroid medication called Medrol Dose Pak can reduce pain, nausea, and opioid use after knee replacement surgery compared to standard post-surgery care.See study design

What are the potential side effects?

Possible side effects of Methylprednisolone include increased blood sugar levels, mood swings, increased risk of infection, high blood pressure, and stomach ulcers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in Nausea score during Follow Up Period

Changes in Pain Score during Follow up period

Secondary outcome measures

Changes in post operative knee function utilizing Knee injury and Osteoarthritis Outcome Score (KOOS)

Changes in the postoperative range of motion following total knee arthroplasty (TKA)

Compare patient satisfaction with acute postoperative pain control

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental Group: Medrol DoseExperimental Treatment1 Intervention

The perioperative Medrol dose treatment will consist of a course that lasts six days, with 24 milligrams administered on the first day, 20 milligrams on the second day, 60 milligrams on the third day, 12 milligrams on the fourth day, 8 milligrams on the fifth day, and 4 milligrams on the sixth day. Patients will then be followed up at the clinic for six weeks following their procedure to allow for clinical evaluation and to measure outcome variables.

Group II: Control Group: Standard of CareActive Control1 Intervention

Patients in this group will receive a single intraoperative dose of 10 mg intravenous dexamethasone (control group, IV dexamethasone is standard of care).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methylprednisolone

2015

Completed Phase 4

~2280

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,640 Previous Clinical Trials

2,560,457 Total Patients Enrolled

Ajay Premkumar, MDPrincipal InvestigatorEmory University

Media Library

Experimental Group: Medrol Dose Clinical Trial Eligibility Overview. Trial Name: NCT05859269 — Phase 4

Knee Arthritis Research Study Groups: Experimental Group: Medrol Dose, Control Group: Standard of Care

Knee Arthritis Clinical Trial 2023: Experimental Group: Medrol Dose Highlights & Side Effects. Trial Name: NCT05859269 — Phase 4

Experimental Group: Medrol Dose 2023 Treatment Timeline for Medical Study. Trial Name: NCT05859269 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include participants of senior age?

"This clinical trial seeks participants over the age of 18 and younger than 95 to take part in the study."

Answered by AI

How can I become a participant in this clinical trial?

"To qualify for this medical experiment, individuals must have knee osteoarthritis and be between 18 to 95 years old. There is a total of 200 slots available."

Answered by AI

What potential risks come with taking Medrol Dose from Experimental Group?

"Due to the Phase 4 trial status of Experimental Group: Medrol Dose, our team has assigned a score of 3 for its safety rating. This level indicates that this treatment is already approved for public use."

Answered by AI

Is this clinical research program still in need of participants?

"As per the data available on clinicaltrials.gov, no more patients are being recruited for this trial which was initially put up on June 1st 2023 and last updated in May 5th of the same year. Although recruitment is closed for now, there are a total of 405 other medical studies actively looking out for volunteers at present."

Answered by AI

What outcome does this trial endeavor to achieve?

"The principal objective of this research is to gauge the alteration in nausea ratings during a post-surgical week. Additional objectives include quantifying range of motion after TKA, comparing patient contentment with operative pain relief and evaluating opiate consumption measured by clinical tablets consumed over the same period."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Methylprednisolone Taper, Lower Extremity

Ajay Premkumar 2023. "Methylprednisolone Taper, Lower Extremity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05859269.